Complications arising from medicines treatment are the most common cause of adverse events in hospital patients and generate adverse publicity for the concerned health service. Errors may occur from the initial decision to prescribe to the final administration of the medicine, and include choice of the wrong medicine, dose, route, form, and/or frequency or time of administration. In the United Kingdom, the National Patient Safety Agency has received 71,000 medicines incident reports since 2001.
The drug use process includes the prescribing, transcribing, manufacturing or compounding, dispensing and administration of a drug, and monitoring therapy. Intravenous therapy is complex and high risk and usually requires the manipulation of a medicine before administration to the patient. There have been deaths and harm following intravenous therapy due to administration of the wrong drug, dose, route and diluent. Clinical studies have identified very high error rates in preparing and administering intravenous medicines in hospitals.
The process of preparing an intravenous medicine for administration involves correct interpretation of a prescription; correct drug calculation; selection of the correct drug, strength, form, reconstitution fluid, diluent and final container; use of appropriate equipment and technique during preparation; correct labelling of the final product; and correct administration including use of an IV pump. At each stage, errors can occur with the potential to cause harm to patients.
The final check before the prepared medicine is ‘released’ for administration to the patient involves checking any calculations, inspection of the products used in preparation and assessment of the final product including labelling. Quantitative assays of final products are never performed in clinical areas and rarely in pharmacy prepared doses. As a result, the true error rate and therefore harm caused is unknown.
Pharmacists and nurses who are responsible for the final preparation and dilution of drug products to be injected prior to their administration to a patient are charged with performing a final check of the prepared product prior to its administration. However, if the final check is performed by the same person who prepared the product, any error that may have occurred in the course of the drug preparation, i.e. selection of the wrong drug product, errors in the calculation of the required drug dose or diluents to be added, mislabelling of the package or container, etc., are prone to being missed a second time during the check.
If the product is checked by another individual, the checking is difficult to perform, as the second individual is looking at a clear liquid within an IV bag or a syringe, and being asked to confirm that the correct clear liquid was added to another clear liquid in exactly the correct volume to produce the final product.
Other systems have been introduced to this process which either involve the removal of a sample of the final drug package in order to evaluate that sample within special sampling reservoirs by NIR (Near Infra Red) spectroscopy. Another system integrates extensive software and workstations to identify the weights of intermediate preparation steps and barcodes of products selected during the preparation process to guarantee that the correct product is produced. However, this system is difficult to achieve, especially on all of the patient care areas where many drug products are prepared.
This apparatus should permit to reduce medication errors and therefore improve patient safety. In November 2005, a study carried out by the National Audit Office in the United Kingdom found that 2081 people had died due to medication errors. And over 980,000 patient safety incidents had been reported.
According to the National Patient Safety Agency “the research indicates that the incidence of errors in prescribing, preparing and administering medicines to be injected is higher than for other forms of medicine. In one study, at least one error in 49% of intravenous medicine doses prepared and administered on hospital wards; 1% of errors were judged to be potentially severe; and 29% potentially moderate errors.” (NPSA, March 2007)
Currently there exists no system for verifying that the correct cytotoxic drugs have been selected and prepared according to a doctor's prescription. There are no means to go back later and prove that what was prepared was done correctly. Some systems are currently seeking to deploy cameras to provide photographic evidence that the correct drug was utilized and scales inserted into the process to confirm through intermediate weighing steps, that the correct amount of drug was added to an IV bag or syringe. These steps are costly and time consuming, but are indicative of the level of concern that has arisen.
In addition to the errors that are caused by medical personnel preparing cytotoxics, one can regularly read about concerns by regulatory agencies over the integrity of the supply chain within which our drug products are produced and often imported. Counterfeit drugs are a source of concern for most governments, and there is little to no process by which hospitals have technologies that can identify compromised drug products.
It is believed that the successful development of a new apparatus for the “Final Check” in the preparation of cytotoxics within health systems will provide the following:
a. An affordable means to rapidly validate the integrity of a chemotherapy preparation before the drug is sent to the patient care area for administration.
b. A system that does not require sample preparation and can be performed within the prepared packages to be sent to the patient care area.
c. A system whose results can generally be obtained in less than 15 seconds
d. A system which can be operated by reasonably low level technical personnel with minimal training required.